Gastrointestinal barrier dysfunction is now recognized as an early event in the pathogenesis of several problematic diseases, such as inflammatory bowel disease (IBD), Parkinson's disease, Crohn's disease, celiac disease and type 1 and 2 diabetes mellitus. There is a critical need, both in clinics and research, for a way to efficiently map and quantify leaky regions of the gastrointestinal (GI) tract. Permeability testing is becoming one of the prominent ways of characterizing changes in small intestine histology, malabsorption of nutrients, and abnormal permeability of the intestinal mucosa. Gastrointestinal permeability can be assessed noninvasively by analyzing saccharide biomarkers in urine such as sucrose for upper GI permeability, lactulose and mannitol for small intestine permeability. The synthetic sweetener sucralose is the main probe of choice for colonic permeability. Current methods for analyzing these biomarkers require expensive and time consuming instrumentation such as high performance liquid chromatography/mass spectrometry (HPLC/MS).
Devices and methods for sensing glucose in solution are described elsewhere, for example in, U.S. Pat. Nos. 6,653,141, 6,627,177, 7,470,420, 7,968,714, and 8,394,357, and Patent Application Publication Nos. US 2004-0028612 A1, US 2009-0148956 A1, US 2012-0009126 A1, and US 2013-0121925 A1, the entire disclosure of all of which is incorporated by reference herein, including the drawings. However, these documents disclose the sensing of glucose, a monosaccharide. Further, chemical strategies for altering chlorinated sugar derivatives (e.g., sucralose) such that they can be detected and quantified are not described.
Thus, there is a need in the art for a low cost, high throughput urinalysis assay that will detect chlorinated saccharide biomarkers in urine. This would enable clinicians to immediately gain insight about microscopic tissue damage that cannot be seen by endoscopy.